Table 1.

Afatinib activity in breast cancer: main studies

Authors	N° patients	Study design	Key clinical results
Hickish et al22	41	Phase 2: patients with stage IIIb or IV breast cancer progressed on trastuzumab treated with afatinib 50 mg/day monotherapy	11% PR; 43% SD AE: diarrhea (24%) and skin rash (10%) G3
Harbeck et al24	56	Phase 2: patients with HER2 negative hormone receptor positive or triple negative, metastatic breast cancer progressed on no more than two chemotherapies, treated with afatinib 50 mg/day monotherapy	No ORR PFS: 54 days for the HER2 negative and hormone receptor positive group; 52 days for the triple negative group AE: manageable
Gunzer et al26	30	Phase 2: patients with stage IIIb or IV breast cancer progressed on letrozole, treated with the combination of letrozole plus afatinib	25% SD (for more than 16 weeks) AE: manageable

Abbreviations: PR, partial response; SD: stable disease; AE, adverse event; G, grade; ORR, overall response rate; PFS, progression free survival.